Initial screening and enrollment of participants has begun in the pioneer phase 2 clinical trial (NCT04251182) for early-to-mild Alzheimer disease (AD). The investigational small molecule (T3D-959,T3D Therapeutics, Research Triangle Park, NC) being evaluated is an agonist of the peroxisome proliferator activated nuclear receptor delta/gamma (PPAR d/g), which regulates blood sugar and triglyceride levels.
Warren Strittmatter, MD, chief medical officer of T3D, emeritus professor of Neurology at Duke University Medical Center and Alzheimer Association Zenith Award winner said, "We are excited to expand our testing of T3D-959 in AD patients in this new phase 2 study. It uniquely targets inherent dysfunctional brain metabolism which we believe underlies the formation of plaques, tangles, and inflammation in this disease".
"We are encouraged by the recent data from our exploratory, feasibility phase 2a trial of T3D-959, in which T3D-959 was well-tolerated and evidenced multiple signals of potential efficacy, setting a foundation for the pioneer study," said John Didsbury, PhD, chief executive officer of T3D.
The phase 2 pioneer trial will assess the longitudinal safety, tolerability, clinical efficacy, and pharmacodynamics of the PPAR d/g agonist, as well as its effects on biomarkers of neurodegeneration. The study will enroll AD participants with mild to moderate disease severity.
Farhat Husain, MD; Divya Singhal, MD; and Sergio Ramirez Salazar, MD
Neha M. Kramer, MD; Jessica Besbris, MD; and Rima M. Dafer, MD, MPH
Stefan Nicolau, MD, and Elie Naddaf, MD